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ISO 13485  is the international QMS standard for medical devices. In the U.S., FDA’s QMSR takes effect Feb 2, 2026 , incorporating ISO...

In 510(k) , substantial equivalence (SE)  means your device has the same intended use  as a predicate  and either the same tech...

An RTA hold  happens when a 510(k)  fails FDA’s acceptance review  and is not accepted  for substantive review; you then have 180 days...

eSTAR  is FDA’s interactive PDF template that structures medical-device submissions in the same layout reviewers use, with built-in...

An FDA Pre-Submission (Q-Sub)  is a voluntary  way to get FDA feedback—by written response and/or a meeting—before or during an IDE,...

An HDE  is a marketing application for a Humanitarian Use Device (HUD) —a device intended to treat/diagnose a condition that affects or...

An Investigational Device Exemption (IDE)  lets an unapproved  or new-use  device be used in a U.S. clinical study to collect...

The FDA Breakthrough Devices Program gives truly novel, life-saving technologies a faster lane through 510(k), De Novo or PMA review. As...

Most SaMD 510(k)s  hit a first-cycle Additional Information (AI) letter , not a final rejection. The recurring issues: missing...

The De Novo  pathway provides marketing authorization  for novel, low–to–moderate-risk  devices without a predicate , creating a new...

Premarket Approval (PMA)  is FDA’s most rigorous pathway, used for most Class III devices  (those that support/sustain life, prevent...

A 510(k) premarket notification  is how most moderate-risk devices show substantial equivalence  to a legally marketed predicate . If...

Choosing an FDA pathway hinges on risk, novelty, and predicates. Use 510(k)  when a suitable predicate exists for the same intended use...

To structure SaMD clinical evidence, build three pillars: valid clinical association  (link SaMD output to the condition), analytical...

In 2025, FDA reviews a risk-based  software evidence package per the Device Software Functions (DSF)  guidance: choose Basic  or Enhanced...

FDA’s Jan 7, 2025 draft  for AI-enabled device software functions  recommends including: model description, dataset lineage/partitions...

In June 2025  FDA finalized its cybersecurity guidance and clarified §524B  obligations for “ cyber devices .” For SaMD that connects to...

Integrate IEC 62304  (software lifecycle) with ISO 14971  (risk management) by mapping hazards → requirements → design → tests →...

Use an FDA Pre-Submission (Q-Sub)  when your SaMD has novel tech/claims , unclear classification/pathway , clinical evidence  questions,...

Starting October 1, 2025 , all De Novo requests for SaMD  must be submitted using the FDA’s eSTAR template . This shift brings new module...